Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibr... | NCT07464132

Studies
Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases

NCT07464132

Sponsor

Peking Union Medical College Hospital

Status

Recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Tumor
Cardiovascular Diseases
Pulmonary Fibrosis
Rheumatic Immune Diseases Involving Large Blood Vessels
Hypertrophic Cardiomyopathy (HCM)
Other Hypoxic and Fibroblast Activated Diseases

Interventions

Injection of 68Ga-NI-FAPI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2025Actual

Primary Completion Date

Feb 17, 2027Estimated

Completion Date

Jun 17, 2027Estimated

First Submitted Date

Mar 3, 2026

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NI-FAPI group	Experimental	Injection of [68Ga]Ga-NI-FAPI	Drug: Injection of 68Ga-NI-FAPI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection of 68Ga-NI-FAPI	Drug	Subjects were injected with 68Ga-NI-FAPI at 0.4-0.5mci/kg body weight	NI-FAPI group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04	Semi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)	Within 30-120 minutes after intravenous injection of imaging agent

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1: 18-85 years old

2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis

3: Ability to understand and sign informed consent forms

4: Expected survival period exceeding 6 months and able to receive follow-up

5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc

Exclusion Criteria:

1: Pregnant or lactating women

2: Patients allergic to research drug ingredients

3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L)

4: Patients who participate in other clinical trials and interfere with the results of this study

5: Patients with severe illness who cannot cooperate with the examination

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhu	Contact	+86-13021115973		yfwyw1999@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Recruiting	Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009369	Neoplasms
D002318	Cardiovascular Diseases
D011658	Pulmonary Fibrosis
D002312	Cardiomyopathy, Hypertrophic

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009202	Cardiomyopathies
D006331	Heart Diseases
D001020	Aortic Stenosis, Subvalvular
D001024	Aortic Valve Stenosis
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases